Why oh why does the ISO 9001 Quality Management Systems standard make the clause for designing products so complicated. Sure, good design prevents problems for both the company producing the product and the customer buying them but, there are other important business considerations in the standard such as continuous improvement and management commitment. So why design gets pages in the standard when other requirements get a line or two is beyond me. Anyhow, my rant is over. Here is what you need to do to meet the requirements of the first section on design for which the standard says –
7 Product Realization
7.3 Design and Development
7.3.1 Design & Development Planning
The organisation shall plan and control the design and development of product.
During the design and development planning, the organization shall determine:
a) the design and development stages,
b) the review, verification and validation that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.
The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses.
NOTE: Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organisation.
Let’s break this up. Firstly the standard tells us that if we are designing a product (or service as the standard always uses the term “product” for both) we must have a plan. The purpose of the plan is to ensure that the product we design meets the customer’s requirements (I have to add for the sake of the business, that it does so with as little waste, and as few problems as possible). The product or service may also need to meet statutory and regulatory requirements. For example, bike helmets and baby’s cots must comply with Australian Standards.
This plan should contain:
- The steps you go through in designing a product or service.
- Who is responsible for completing each step – a name or job title.
- When the step is to be completed – a timeline.
- Any tests to be performed at each step – to determine whether the design will meet customer and legal requirements.
- How you will validate that the design meets the customer’s and legal requirements – this is often done during the final testing stages but it might also be need during development. For example, when designing automation software, the engineers will test (validate) that the software works on the customer’s premises when connected to their machines.
- How you will review the design – this is normally done at one or more milestones in the design process. The purpose of the review is to check progress, whether the design is meeting requirements, and to check costs.
Your plan must be dynamic and updated as requirements and circumstances change. It should also include how you communicate progress. Some companies do this by holding regular project or design meetings.
A multi-disciplinary approach to design works best. By including other departments such as quality, engineering, purchasing, sales, and production, for example, you are far more likely to get the design right. Consider including customer and supplier personnel at appropriate stages for the same reason.
I have seen design plans that are a simple checklist and those that are in Microsoft Project and other software designed specifically for design and project management. The complexity of your design plan will depend on the size and length of the contract or project, the product or service risk, product life, customer and regulatory requirements, the cost of getting it wrong, your past experiences with similar products or services, and so on.
As I always say, keep it as simple as you can.
Do you need it?
You must include product design and development in your ISO 9001 Quality Management System if you contract or convey the perception that you design product, regardless whether you buy the designs, outsource the design process, or actually do design and development yourself. If you don’t fall into that category then exclude it from your system. Here is guidance on exclusions straight from the horse’s mouth, the International Organization for Standardization.
All the best – Liz